BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Disposable Gloves Size L

    DI: 04007418924016 · Model: 92401 · Hans Hepp GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    4

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    Basic Information

    Brand Name
    Disposable Gloves Size L
    Primary DI
    04007418924016
    Version / Model
    92401
    Company Name
    Hans Hepp GmbH & Co. KG
    Labeler DUNS
    315896217
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    4
    Record Status
    Published
    Publish Date
    2023-08-11
    Public Version
    2
    Public Version Date
    2026-04-23
    Public Version Status
    Update
    Public Device Record Key
    0bf18b1a-df6c-466b-a32c-b8688518f006

    Device Description

    A non-sterile device made of vinyl intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with talcum powder and it does not have antimicrobial features. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LYZ Vinyl Patient Examination Glove

    GMDN Terms

    Code Name
    47176 Vinyl examination/treatment glove, non-powdered

    Identifiers

    Type ID
    Unit of Use 04007418924511
    Primary 04007418924016

    Premarket Submissions

    Submission Number Supplement Number
    K170575 000